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24.09.2020 | Original Article

Results of a randomized controlled phase III trial: efficacy of polyphenol-containing cystus® tea mouthwash solution for the reduction of mucositis in head and neck cancer patients undergoing external beam radiotherapy

verfasst von: Dr. med. Nadja Ebert, Dr. med. dent. Anna Kensche, Prof. Dr. rer. nat. Steffen Löck, Wahyu Wijaya Hadiwikarta, PhD, Dr. med. dent. Anna Hänsch, Prof. Dr. med. vet. Wolfgang Dörr, Prof. Dr. med. Mechthild Krause, Prof. Dr. med., Prof. Dr. med. dent. Christian Hannig, Prof. Dr. med. Michael Baumann, Prof. Dr. med.

Erschienen in: Strahlentherapie und Onkologie | Ausgabe 1/2021

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Abstract

Purpose

To determine the effect of Cystus® tea (Naturprodukte Dr. Pandalis GmbH & Co. KG) as mouthwash compared to sage tea on oral mucositis in patients undergoing radio(chemo)therapy for head and neck cancer.

Methods

In this randomized, prospective phase III study, 60 head and neck cancer patients with primary or postoperative radio(chemo)therapy were included between 04/2012 and 06/2014. They received either sage or Cystus® tea for daily mouthwash under therapy. Mucositis was scored twice a week following the Radiation Therapy Oncology Group and the European Organization for Research and Treatment Cancer (RTOG/EORTC) scoring system. Dental parameters were also recorded. Statistical evaluation of the primary endpoint was performed using t‑test and log rank test.

Results

Data from 57 patients could be evaluated. Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®). A total of 55 patients received the prescribed dose (60–66 Gy postoperative; 70–76.8 Gy primary). Mucositis grade 3 was observed in 23 patients (n = 11 sage; n = 12 Cystus®) and occurred between day 16 and 50 after start of therapy. There was no significant difference between the two groups in latency (p = 0.75) and frequency (p = 0.85) of the occurrence of mucositis grade 3. The self-assessment of the oral mucosa and the tolerability of the tea also showed no significant differences. Occurrence of dental pathologies appeared to increase over time after radiotherapy.

Conclusion

Cystus® and sage tea have a similar effect on the occurrence of radiation-induced mucositis regarding latency and incidence. Cystus® tea mouthwash solution is tolerated well and can be applied in addition to intensive oral care and hygiene along with the application of fluorides.

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Titel: Results of a randomized controlled phase III trial: efficacy of polyphenol-containing cystus® tea mouthwash solution for the reduction of mucositis in head and neck cancer patients undergoing external beam radiotherapy
verfasst von: Dr. med. Nadja Ebert
Dr. med. dent. Anna Kensche
Prof. Dr. rer. nat. Steffen Löck
Wahyu Wijaya Hadiwikarta, PhD
Dr. med. dent. Anna Hänsch
Prof. Dr. med. vet. Wolfgang Dörr
Prof. Dr. med. Mechthild Krause, Prof. Dr. med.
Prof. Dr. med. dent. Christian Hannig
Prof. Dr. med. Michael Baumann, Prof. Dr. med.
Publikationsdatum: 24.09.2020
Verlag: Springer Berlin Heidelberg
Erschienen in: Strahlentherapie und Onkologie / Ausgabe 1/2021
Print ISSN: 0179-7158
Elektronische ISSN: 1439-099X
DOI: https://doi.org/10.1007/s00066-020-01684-y

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Results of a randomized controlled phase III trial: efficacy of polyphenol-containing cystus® tea mouthwash solution for the reduction of mucositis in head and neck cancer patients undergoing external beam radiotherapy

Abstract

Purpose

Methods

Results

Conclusion

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Abstract

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Conclusion

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